Evaluating outpatient care versus hospitalization for patients with chest pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the effectiveness of a rapid outpatient evaluation strategy against traditional hospitalization for patients experiencing moderate risk chest pain. Patients will be randomized in the Emergency Department to receive either outpatient follow-up or hospitalization for further evaluation. The outpatient approach, known as CARE-CP, focuses on timely follow-up within 72 hours to manage cardiovascular risk factors and determine the need for additional cardiac testing. The goal is to improve patient-centered outcomes while reducing healthcare costs and resource strain associated with unnecessary hospitalizations.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥21 years old
* Chest pain or Symptoms of acute coronary syndrome (ACS)
* Moderate risk of ACS (all of the below)
* Hear Score 4-6
* Non-Ischemic electrocardiogram (ECG)
* Two Troponin measures \< Sex-Specific Upper Reference Limit

  * Women \<15 pg/ml
  * Men \<20 pg/ml
* No prior coronary artery disease (CAD)

  * No Prior Myocardial Infarction (MI)
  * No Prior Coronary Revascularization Procedures
  * No Patients with ≥ 70% Obstructive Coronary Disease

Exclusion Criteria:

* ST Elevation Myocardial Infarction (STEMI) Activation
* ST Changes or new T-wave inversions ≥1mm on ECG
* Any Elevated Troponin Measure (Based on Sex-Specific 99th Percentile)
* Serial change between Troponin Measures (Delta) ≥5 pg/mL
* Stress Echocardiography, Nuclear Stress Test, Stress ECG, Stress Cardiac MRI, Coronary CT Angiogram (CCTA), Invasive Coronary Angiography (Cardiac Cath) within 1 year
* "Clean" CCTA or Cardiac Cath (0% stenosis in all vessels) within the past 2 years
* Chest Trauma
* Pregnancy
* Life Expectancy \< 1 year
* Other comorbid conditions requiring hospitalization
* Unstable Vitals (Blood Pressure \<90, Heart Rate \>120 or \<50, O2 Sat \<90%)
* End Stage Renal Disease; Dialysis or estimated glomerular filtration rate (eGFR) \<30 mL/min
* Transfers From Another Hospital
* Non-English Speaking
* Prisoners
* Prior Enrollment
* Already Enrolled in Other Interventional Trial

Where it's running

• Henry Ford Hospital
  Detroit, Michigan, United States Recruiting
• Carolinas Medical Center
  Charlotte, North Carolina, United States Recruiting
• Wake Forest University Health Sciences
  Winston-Salem, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Simon Mahler, MD, MS — Wake Forest University Health Sciences
• Study coordinator: Lauren Koehler
• Email: Lauren.Koehler@Advocatehealth.org
• Phone: 336-716-4646

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.